Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Prevention	Completed	Over 18	NCI	GUMC-19196 NCI-P97-0118

Objectives

I.  Compare, in patients with prior resection of respiratory tract carcinoma, 
the levels of the following intermediate biomarkers before and after 
acetylcysteine (N-acetylcysteine; NAC) administration:  cellular reduced 
glutathione (GSH) levels, DNA adducts, DNA repair activities, and PCNA 
expression.  

II.  Compare the association between the augmentation of cellular GSH and that 
of other measurements in order to evaluate whether the chemopreventive 
properties of NAC are mediated through GSH.

III.  Assess the NAC-related augmentation of cellular GSH levels in normal 
appearing oral tissue and lymphocytes. 

Entry Criteria

Disease Characteristics:

Previous resection for carcinoma of the respiratory tract
 Curatively treated stage I-IV tumor of the head and neck 
  Invasive squamous cell carcinoma of oral cavity, oropharynx, hypopharynx,
  or larynx

Must also be one of the following:
 Chronic smoker with at least 20 pack per year history, OR
 Prior history of alcohol consumption with at least 7 drinks/week for at least
  a year

No synchronous tumors

Prior/Concurrent Therapy:

Biologic therapy:
 At least 6 months since biologic therapy or immunotherapy

Chemotherapy:
 At least 6 months since chemotherapy

Endocrine therapy:
 Not specified

Radiotherapy:
 At least 6 months since completion of prior radiotherapy

Surgery:
 At least 21 days since any major surgery
 At least 6 months since completion of surgical resection 

Other:
 No concurrent enrollment in head and neck cancer treatment or chemoprevention
  study
 No concurrent investigational drugs
 At least 6 months since taking "megadose" vitamins (greater than 25,00 IU)

Patient Characteristics:

Age:
 Over 18

Performance status:
 ECOG 0-1

Life expectancy:
 At least 1 year

Hematopoietic:
 Absolute granulocyte count greater than 1,500/mm3
 Platelet count greater than 200,000/mm3

Hepatic:
 Bilirubin no greater than 1.0 mg/dL
 SGOT and SGPT no greater than 100 IU/L 

Renal:
 Creatinine no greater than 1.7 mg/dL

Other:
 Triglycerides no greater than 190 mg/dL
 Cholesterol no greater than 240 mg/dL
 No recent weight loss of greater than 10% of current body weight
 No frequent vomiting or poor alimentation
 Not pregnant or nursing
 Adequate contraception required of all fertile patients

Expected Enrollment

There will be 30 patients accrued into this study.

Outline

This is a single arm study.

Acetylcysteine (N-acetylcysteine; NAC) is given orally every day for 3 months 
in the absence of unacceptable toxicity.  Biomarker measurements are performed 
at baseline and after NAC treatment.  

During treatment, smoking/alcohol cessation activities are monitored monthly.  
At end of 3 month treatment period, a guide to quitting smoking is provided.

Trial Contact Information

Trial Lead Organizations

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Bruce Davidson, MD, Protocol chair		Ph: 202-444-8186 Email: davidsob@georgetown.edu